Actively Recruiting
Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders
Led by Northwestern University · Updated on 2026-05-01
30
Participants Needed
1
Research Sites
468 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder. The total clinical study duration will be 26 months (104 Weeks). The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.
CONDITIONS
Official Title
Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged over 6 months at screening visit
- Clinical diagnosis of a genetic skin disorder at screening, ideally confirmed by genetics or histology
- Have one or more gene variants identified by genotyping or willing to provide a sample for genetic testing before treatment
- Average Itch Numerical Rating Scale (NRS) score of 4 or higher and Worst Itch NRS of at least 5 during the prior 7 days (self-reported if over 8 years old; proxy reported if under 8 years old)
- Willing to provide weekly itch severity information and wear a sensor device to track itch and sleep during the first 24 weeks
- Able and willing to follow study restrictions and requirements
- Subject or caregiver able to understand and complete study questionnaires and requirements
You will not qualify if you...
- Age under 6 months at screening visit
- Unable to provide informed consent or assent, or lack of consent from legal representative if under 18 years
- Diagnosis of ichthyosis vulgaris as the only inherited disorder
- Use of dupilumab within 105 days before baseline visit
- Use of immunosuppressive or systemic anti-inflammatory drugs, phototherapy, or other biologics within specified time frames before baseline visit
- Initiation of topical or systemic retinoids, keratolytics, or anti-inflammatory agents within 4 weeks before study start
- Active infections, recent serious infections, malignancies, or severe uncontrolled medical conditions
- Treatment with live vaccines within 4 weeks before starting dupilumab
- Active infection requiring systemic antimicrobial treatment within 2 weeks before starting dupilumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
N
Northwestern Dermatology CTU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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